HEINE OMEGA 500
Device Facts
| Record ID | K123316 |
|---|---|
| Device Name | HEINE OMEGA 500 |
| Applicant | Heine Optotechnik GmbH & Co. KG |
| Product Code | HLI · Ophthalmic |
| Decision Date | Feb 26, 2013 |
| Decision | SESE |
| Submission Type | Abbreviated |
| Regulation | 21 CFR 886.1570 |
| Device Class | Class 2 |
| Attributes | 3rd-Party Reviewed |
Intended Use
The indirect Ophthalmoscope HEINE OMEGA® 500 is an AC-powered or battery powered device for medical professionals, containing illumination and viewing optics intended to examine the media (cornea, aqueous, lens, vitreous) and the retina of the eye.
Device Story
HEINE OMEGA 500 is a head-mounted binocular indirect ophthalmoscope used by medical professionals to examine the patient's retina and ocular media. The device provides illumination and viewing optics; it is powered by either a rechargeable battery pack or mains power supply. The examiner wears the device on their head, adjusting the interpupillary distance and light apertures to achieve a focused view of the fundus. The device does not collect or display data; it serves as a direct visualization tool. By providing adjustable illumination and magnification, it enables clinicians to perform retinal examinations, aiding in the diagnosis and monitoring of ocular conditions. The device is intended for use in clinical settings.
Clinical Evidence
Bench testing only. The device was evaluated for optical radiation hazards per ISO 10943 and fundamental requirements per ISO 15004-2. Retinal irradiance was measured and compared to predicate devices, confirming that the light output levels are within safe limits for clinical use.
Technological Characteristics
Head-mounted binocular indirect ophthalmoscope. Materials: Aluminum, leather, brass, steel, plastics. Illumination: White LED or 5W XHL Xenon Halogen lamp. Power: Rechargeable battery (mPack) or 100-240Vac mains. Features: Adjustable light apertures (small, middle, large circles), interpupillary distance adjustment (46-74 mm), +2 diopter viewing optics. Electrical safety: IEC 60601-1 compliant. No software or data processing.
Indications for Use
Indicated for medical professionals to examine the media (cornea, aqueous, lens, vitreous) and retina of the eye in patients. No specific contraindications listed.
Regulatory Classification
Identification
An ophthalmoscope is an AC-powered or battery-powered device containing illumination and viewing optics intended to examine the media (cornea, aqueous, lens, and vitreous) and the retina of the eye.
Special Controls
*Classification.* Class II (special controls). The device, when it is an AC-powered opthalmoscope, a battery-powered opthalmoscope, or a hand-held ophthalmoscope replacement battery, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.
Predicate Devices
- Vantage Plus Binocular Indirect Ophthalmoscope (K060822)
- NEITZ Binocular Indirect Ophthalmoscope IO-A (K942712)
- Model #12000 Binocular Indirect Ophthalmoscope (K930023)
Related Devices
- K142837 — HEINE SIGMA 250 & HEINE SIGMA 250 M2 · Heine Optotechnik GmbH & Co. KG · Jan 29, 2015
- K123587 — HEINE MINI 3000 LED OPHTHALMOSCOPE · Heine Optotechnik GmbH & Co. KG · Mar 22, 2013
- K131961 — HEINE BETA 200(R) OPHTHALMOSCOPE · Heine Optotechnik GmbH & Co. KG · Dec 4, 2013
- K131719 — OPHTHALMOSCOPES DIAGNOSTIC INSTRUMENT KITS · Medical Devices (Pvt) , Ltd. · Oct 30, 2013
- K061278 — OPTYSE OPHTHALMOSCOPE · Ophthalmos , Ltd. · May 16, 2006
Submission Summary (Full Text)
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K123316
HEINE Optotechnik GmbH & Co. KG · Kientalstr. 7 · 82211 Herrsching · Germany Tel. +49(0)8152/38-0 · Fax +49(0)8152/38-202 · E-Mail: info@heine.com · www.heine.com
.
FEB 2 6 2013
Image /page/0/Picture/4 description: The image shows a logo with a triangle shape. Inside the triangle, there is a stylized letter 'S' that forms a snake-like shape. The word 'HEINE' is written in a stylized font across the base of the 'S' and the triangle. The logo appears to be a company or brand identifier.
510(k) Summary of Safety and Effectiveness
### Submitter Information:
HEINE Optotechnik GmbH & Co. KG Kientalstr. 7 82211 Herrsching Germany Registration Number: 1000379039 Owner/Operator Number: 9003020
### Official Correspondent:
Mr. Jörg Rönnau Director Regulatory Affairs HEINE Optotechnik GmbH & Co. KG Phone: +49 8152 38 0
US Agent (Contact):
Benoit St. Jean HEINE USA, Itd. 10 Innovation Way Dover, NH 03820 USA Phone: +1 603 7427217 ·· E-mail: Bstjean@heine-na.com
Date Prepared:
Common Name:
September 3rd, 2012
Device(s) Identification: Device Trade Name:
HEINE OMEGA® 500 Indirect ophthalmoscope
### Classification of the device:
Device Classification Name: Product Code: Device Classification No.: Panel: Regulatory Status:
Ophthalmoscope HLI (AC) and HLJ (DC) Part 886.1570 Ophthalmic Devices (86) Class II
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Image /page/1/Picture/1 description: The image shows a logo for Heine. The logo is a triangle with a snake wrapped around a staff inside of it. The word "HEINE" is written in a stylized font across the middle of the triangle.
### Device Description:
The HEINE OMEGA® 500 is an indirect ophthalmoscope, worn on the user's head to provide illumination and viewing optics in order to examine the retina of a patient's eve. The ophthalmoscope can be operated either by rechargeable battery or directly by mains power supply.
The HEINE OMEGA® 500 allows wireless comfortable movement for the user and mobile charging (depending on chosen power source).
### Intended Use:
The indirect Ophthalmoscope HEINE OMEGA® 500 is an AC-powered or battery powered device for medical professionals, containing illumination and viewing optics intended to examine the media (cornea, aqueous, lens, vitreous) and the retina of the eye.
| Predicate devices: |
|----------------------------------------------------------------------|
| Device Trade Name:<br>Vantage Plus Binocular Indirect Ophthalmoscope |
| Applicant:<br>Keeler Instruments Inc. |
| 510(k) No.:<br>K060822 |
| Device Trade Name:<br>NEITZ Binocular Indirect Ophthalmoscope IO-A |
| Applicant:<br>NEITZ Instruments Company, Ltd. |
| 510(k) No.:<br>K942712 |
| Device Trade Name:<br>Model #12000 Binocular Indirect Ophthalmoscope |
| Applicant:<br>Welch Allyn, Inc. |
| 510(k) No.:<br>K930023 |
The HEINE OMEGA 500 is considered substantial equivalent to the Vantage Plus Binocular Indirect Ophthalmoscope (K060822), NEITZ Binocular Indirect Ophthalmoscope IO-A (K942712) and Welch Allyn Model #12000 Binocular Indirect Ophthalmoscope (K930023).
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| Следия владии с Анар. ССРАСАНИЯСТ РАСОВОМОСРЕДАРА ССАВААЛ И. В МАРА . 1. 4<br>- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - |
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| And and the coupling of the state of program with are and the second of the<br>10 1 1 18 1882 1974 1991 1991 1992 1992 1991 1991 19 11 |
| 510(k) applied<br>(predicate<br>devices) | HEINE OMEGA 500 | Keeler Vantage Plus | NEITZ IO-a LED | Welch Allyn Model #12000 | Assessment |
|-------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Indication for<br>use | New device, for which a<br>510(k) is applied | 510(k) Number:<br>K060822 | 510(k) Number:<br>K942713 | 510(k) Number:<br>K930023 | same |
| | The indirect Ophthalmoscope<br>HEINE OMEGA® 500 is an<br>AC-powered or battery<br>powered device for medical<br>professionals, containing<br>illumination and viewing optics<br>intended to examine the<br>media (cornea, aqueous, lens,<br>vitreous) and the retina of the<br>eye | The Keeler Vantage Plus<br>Indirect Ophthalmoscope is<br>intended to be used to<br>examine the Cornea,<br>aqueous, lens vitreous and<br>retina of the eye. | An ophthalmoscope is an<br>AC-powered or battery-<br>powered device containing<br>illumination and viewing<br>optics intended to examine<br>the media (cornea, aqueous,<br>lens, and vitreous) and the<br>retina of the eye. | An ophthalmoscope is an<br>AC-powered or battery-<br>powered device containing<br>illumination and viewing<br>optics intended to examine<br>the media (cornea, aqueous,<br>lens, and vitreous) and the<br>retina of the eye. | same |
| | Source: Instructions for use | Source: 510(k) K060822 | Source: 510(k) K942713,<br>Regulation Number:<br>886.1570 | Source: 510(k) K930023,<br>Regulation Number:<br>886.1570 | |
| Method of<br>operation | Used to examine the retina by<br>an examiner in a specified<br>distance to the eye | Used to examine the retina<br>by an examiner in a specified<br>distance to the eye | Used to examine the retina<br>by an examiner in a specified<br>distance to the eye | Used to examine the retina<br>by an examiner in a specified<br>distance to the eye | same |
| Technology | The HEINE OMEGA 500<br>indirect ophthalmoscope has<br>two main elements:<br>1. The illumination<br>element<br>2. The viewing element | The Keeler Vantage Plus,<br>indirect ophthalmoscope has<br>two main elements:<br>1. The illumination<br>element<br>2. The viewing element | The Neitz IO-a LED indirect<br>ophthalmoscope has two<br>main elements:<br>1. The illumination<br>element<br>2. The viewing element | The Welch Allyn Model<br>#12000 indirect<br>ophthalmoscope has two<br>main elements:<br>1. The illumination<br>element<br>2. The viewing element | same |
| Type / Design | indirect ophthalmoscope<br>Binocular (Headband<br>mounted)<br>Permanent | indirect ophthalmoscope<br>Binocular (Headband<br>mounted)<br>Permanent | indirect ophthalmoscope<br>Binocular (Headband<br>mounted)<br>Not available | indirect ophthalmoscope<br>Binocular (Headband<br>mounted)<br>Not available | same |
| Exposure<br>Parameter | | | | | |
| Safety<br>Infrared Filter<br>(IR Blocker) | | | | | |
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Image /page/3/Picture/5 description: The image is a black and white logo. The logo is a triangle with the text "HEINE" written vertically inside. There is a stylized design to the left of the text that appears to be a cursive letter.
| | HEINE OMEGA 500 | Keeler Vantage Plus | NEITZ IO-a LED | Welch Allyn Model #12000 | Assessment | | |
|--------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|------------------------------|------------------------------|
| Selectable filter | Blue, yellow, red-free, diffuser | Blue, red-free, diffuser | Cobalt blue, red-free | Cobalt blue, yellow, red-free, diffusor<br>Information not available | same | | |
| Exposure<br>Parameter<br>Energy<br>Delivered<br>(Light Output) | 507 lx (max.) 258 lx (max.) | 901 lx (max.) | 913 lx (max.) | 600 lx (max.) | refer to<br>justification 1) | | |
| Measured in a<br>distance of 500 mm | | | | | | | |
| min. Irradiance<br>(for retinal<br>imaging) | LED<br>$8,81 mW/cm^2$ | LED<br>$54,87 mW/cm^2$ | Halogen<br>$26,53 mW/cm^2$ | LED<br>$22,10 mW/cm^2$ | Information not available | refer to<br>justification 1) | |
| max. Irradiance<br>(for retinal<br>imaging) | LED<br>$323,54 mW/cm^2$ | Halogen<br>$465,77 mW/cm^2$ | LED<br>$597,66 mW/cm^2$ | Halogen<br>$423:29 mW/cm^2$ | LED<br>$515,03 mW/cm^2$ | Information not available | refer to<br>justification 1) |
| Power sources<br>(Energy used) | Wireless battery pack mPack<br>unplugged:<br>Nominal voltage: 7.4V<br>1850mAh<br><br>Wall mounted unit<br>(EN50 mPack/EN50)<br>Mains voltage: 100-240Vac<br>Belt battery pack (mPack):<br>Nominal voltage: 7.2V<br>4200mAH | Wireless battery pack<br>(Standard Lithium battery):<br>Nominal voltage: 7.4V<br>1800mAh<br><br>Wall pack<br>Input mains data: 100-<br>240Vac<br><br>Belt battery pack (Smart<br>pack):<br>Nominal voltage: 7.2V 2500<br>mAh | Wireless battery pack (same<br>as 2400RD): nominal<br>voltage: 2.4 V min. 1900mAh<br><br>Not available<br><br>Belt battery pack (2400RD)<br>Nominal voltage: 2.4V min.<br>1900mAH | Not Available<br><br>Wall/Desk Power Source:<br>Input: 96-130Vac<br><br>Belt battery pack (Portable<br>Power Source): nominal<br>voltage: 4.8V 1800mAh | same | | |
| Biocompatibility | No contact to the patient | No contact to the patient | No contact to the patient | No contact to the patient | same | | |
| Material | Aluminum<br>Leather<br>Brass<br>Steel<br>Plastics | Aluminum<br>Leather<br>Brass<br>Steel<br>Plastics | Aluminum<br>Leather<br>Brass<br>Steel<br>Plastics<br>Information not available | Aluminum<br>Brass<br>Steel<br>Plastics | same | | |
| Standard for<br>electrical safety | Complies with IEC 60601-1 | Complies with BS EN ISO<br>60601-1 | Information not available | Complies with IEC 601-1 | same | | |
| | HEINE OMEGA 500 | Keeler Vantage Plus | NEITZ IO-a LED | Welch Allyn Model #12000 | Assessment | | |
| Flammability of materials | Low probability. All measures have been taken to use self-extinguishing materials which are either of flame classification HB or V-0 (UL94). The system is illuminated using a LED or 5W XHL Xenon Halogen lamp and all materials used in the vicinity are specially designed to safely operate in high temperature environments. | Low Probability. All measures have been taken to use self-extinguishing materials which are either of flame classification HB or V-0 (UL94). The system is illuminated using a LED and all materials used in the vicinity are specially designed to safely operate in high temperature environments. | not available | not available | same | | |
| Performance based on Ophthalmo-scope Guidance for industry and ISO 10943 | Fulfilled, refer to 510(k) chapter 18c | Fulfilled | Fulfilled | Fulfilled | same | | |
| Illumination | White LED, 6V | White Xenon Halogen LED, 6V bulb | 6V, 5 Watt Xenon filament bulb | White LED | 4,65V, 12 Watt Halogen bulb | same | |
| Light aperturesNote1 | Small circle: 18 mm<br>Middle circle: 39 mm<br>Large circle: 74 mm | 23 mm<br>51 mm<br>68 mm | 19 mm<br>50 mm<br>80 mm | 20 mm<br>50 mm<br>80 mm | refer to justification 2) | | |
| Inter pupillary distance adjustment | 46 - 74 mm | 48 - 76 mm | 54 - 74 mm | 49 - 74 mm | refer to justification 3) | | |
| Data collection and/or display system | None | None | None | None | same | | |
| Lens power viewing optics | +2 diopter | +2 diopter | not available | +2 diopter | same | | |
| Brightness controls | Control dial | Control dial | Control dial | Control dial | same | | |
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Image /page/5/Picture/1 description: The image shows a gray triangle with the word "HEINE" written vertically inside. A wavy line is drawn across the word. The number 19.00 is written below the triangle.
| | HEINE OMEGA 500 | Keeler Vantage Plus | NEITZ IO-a LED | Welch Allyn Model #12000 | Assessment |
|-----------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Maximum temperature of parts of the device held by the operator or accessible to the patient Product viewsNote2 | Complies with IEC 60601-1 | Complies with BS EN ISO 60601-1 | Information not available | Complies with IEC 601-1 | same |
| Total view | Image: HEINE OMEGA 500 Total view | Image: Keeler Vantage Plus Total view | Image: NEITZ IO-a LED Total view | Image: Welch Allyn Model #12000 Total view | same |
| Operator's view | Image: HEINE OMEGA 500 Operator's view | Image: Keeler Vantage Plus Operator's view | Image: NEITZ IO-a LED Operator's view | Image: Welch Allyn Model #12000 Operator's view | |
| Left side | Image: HEINE OMEGA 500 Left side | Image: Keeler Vantage Plus Left side | Image: NEITZ IO-a LED Left side | Image: Welch Allyn Model #12000 Left side | |
| Backside of the headband | Image: HEINE OMEGA 500 Backside of the headband | Image: Keeler Vantage Plus Backside of the headband | Image: NEITZ IO-a LED Backside of the headband | Image: Welch Allyn Model #12000 Backside of the headband | |
| | HEINE OMEGA 500 | Keeler Vantage Plus | NEITZ IO-a LED | Welch Allyn Model #12000 | Assessment |
| Cleaning | Before cleaning, disconnect from the<br>power source.<br>The instrument and the loupe may be<br>wiped clean with a non-shedding<br>damp or dry cloth.<br><br>Wipe the headband with a clean,<br>absorbent, non-shedding cloth<br>dampened with a water/detergent<br>solution (2% by volume). Ensure that<br>excess solution does not enter the<br>instrument. Use caution to ensure<br>cloth is not saturated with solution.<br>The XHL / LED lamp can be cleaned,<br>with a dry cloth if necessary. | Only manual non-immersion<br>cleaning as described below should<br>be used for the instrument. Do not<br>autoclave or immerse in cleaning<br>fluids. Always disconnect power<br>supply from source before cleaning.<br>Wipe external surface with a clean<br>absorbent, non-shedding cloth<br>dampened with a water/detergent<br>solution (2% by volume) or<br>water/isopropyl alcohol solution<br>(70% by volume).<br>Ensure that excess solution does not<br>enter the instrument. Use caution to<br>ensure cloth is not saturated with<br>solution.<br>Surfaces should be carefully hand<br>dried using a clean non shedding<br>cloth.<br>Safely dispose of used cleaning<br>materials. | The newly adopted Head Pad of Wet<br>Suit Material secures the durable<br>wearing of the head band and the<br>utmost comfort. This Washable<br>material is ideal for keeping your<br>instrument neat and clean in use. | The glass cover on the front of the<br>BIO, the glass lenses in the oculars<br>and the teaching mirror can be<br>cleaned with a soft cloth moistened<br>with alcohol. The leather cushions<br>on the headband may be removed<br>and wiped with soapy water. The<br>remainder of the BIO may be wiped<br>with a soft cloth that has been<br>moistened in alcohol. Avoid using<br>harsh cleaning fluids or cloth which<br>are excessively moist on any part of<br>this instrument. | same |
| Disinfection | The instrument headband can be<br>disinfected with CIDEX® OPA by<br>wiping it with a soft cloth moistened<br>with disinfectant for 5 minutes.<br><br>The use of a spray disinfectant and<br>soaking or disinfection in a machine is<br>not permitted.<br>Sterilisation of OMEGA® 500 is not<br>allowed | Do not autoclave or immerse in<br>cleaning fluids.<br><br>No further information denoted | no information denoted | no information denoted | same |
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| Note 1: | The measurements are taken from 500 mm in front of the instrument. |
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| Note 2: | Assessment concerning safety statements |
| Justification 1: | The light output values stated in the table above are the maximum possible values of the devices. The light output value of each device is adjustable from a minimum level up to 100% by an integrated control dial. |
| | The FDA Guidance of Industry "Ophthalmoscope Guidance" advises the manufacturer to provide the following information to the user: "[...] the brightness setting should not exceed what is needed to provide clear visualization of the target structures. [...]". This reflects the market experience of HEINE that doctors accept or even prefer using low levels of illumination. Moreover, these low levels provide the advantage of longer exposure durations until the limits of radiation hazards are reached. Therefore, the probability of ocular damage is less in comparison to exposures with higher illumination. The high light output of the Keeler device was also discussed critically in [12a]. |
| | The "minimum retinal irradiance required for viewing human fundi in indirect ophthalmoscopy" is discussed in [12b]. The authors concluded "... that the minimum retinal irradiance needed for viewing human fundi is less than... 6,3mW/cm²)". |
| | To determine the maximum retinal irradiance of the HEINE OMEGA 500 we set the brightness control of our device to the maximum level in the same way as we did for the determination of exposure parameter in the comparison table above. Then we determined the irradiance according to the test method published in [12c]. |
| | The measured retinal irradiance of HEINE OMEGA 500 ophthalmoscopes is 323,54 mW/cm² (approximately 51 times higher than the required minimum level) for the device equipped with LED illumination and 465,77 mW/cm² (approximately 74 times higher than the required minimum level) for the device equipped with XHL Xenon Halogen Bulb. [12d] |
| | The irradiance of 323,54 mW/cm² of the HEINE OMEGA 500 with LED is lower than the irradiance of the predicate devices. However as indicated [12b] a minimum retinal irradiance of 6,3 mW/cm² is needed for viewing the human fundi. Taking into account these facts we believe, that the light output level of the HEINE OMEGA 500 does not affect the safety or the effectiveness of the device compared to the predicate devices. We regard our device as equivalent. |
| | The different ratios between the measured exposure parameters for the energy delivered (Light Output) measured in lux and the Min and Max. Irradiance measured in mW/cm² can be explained by the following facts: |
| | 1. The lux (symbol: lx) is the Sl unit of illuminance and luminous emittance, measuring luminous flux per unit area. It is equal to one lumen per square meter. In photometry, this is used as a measure of the intensity, as perceived by the human eye, of light that hits or passes through a surface. It is analogous to the radiometric unit watts per square meter, but with the power at each wavelength weighted according to the luminosity function, a standardized model of human visual brightness perception. In English, "lux" is used in both singular and plural. |
| | 2. The Irradiance is a physical parameter measured in "mW/cm²" solely based on physical parameters without human visual brightness perception. Therefore there is no direct correlation between the values measured in lux and the values measured in "mW/cm²" because the lux values depend heavily on the wavelength of the light whereby the Irradiance measures the power of the light in "mW/cm²" without human visual brightness perception. Both values are measured values and therefore calculations can't be provided. |
| References: | |
| [12a] | Kossol J, Cole C, Dayhaw-Barker P.: "Spectral irradiances of and maximal permissible exposures to two indirect ophthalmoscopes" in Am J Optom Physiol Opt. 1983 Jul;60(7):616-21 |
| [12b] | Rockefeller S. L. Young, Morton F. Goldberg, Gerald A. Fishman: "Letter to the editor" in Investigative Ophthalmology & Visual Science, Volume 20, Number 4, May 1981 |
| [12c] | Joseph L. Calkins and Bernard F. Hochmeier: "Retinal light exposure from ophthalmoscopes, slit lamps, and overhead surgical lamps" in Investigative |
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| [12d] | Ophthalmology & Visual Science, Volume 19, Number 9, September 1980<br>Test report - Estimation of irradiance in the retinal plane of HEINE OMEGA 500 indirect ophthalmoscope", Version 1.0, 2012-10-18; HEINE<br>Optotechnik |
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| | Justification 2:<br>Different patients have different anatomical pupil sizes. Therefore the possibility of adjustment of the light apertures of binocular indirect ophthalmoscopes<br>enables the user of the device to adjust the diameter of the illuminated spot individually to the patient's eye. The HEINE OMEGA® 500 offers a slightly smaller<br>diameter of the "small circle" than the NEITZ IO-a. The differences between the new device and the predicate devices do not affect the safety or effectiveness<br>of the device and we regard our device as equivalent to the predicate devices |
| | Justification 3:<br>The interpupillary distance adjustment of binocular indirect ophthalmoscopes allows the individual user of the device to match the distance of the oculars to the<br>interpupillary distance of his eyes to get a singular focused image. The HEINE OMEGA® 500 provides the possibility to adjust the smallest inter pupillary<br>distance of 46 mm. This enables users with eyes that are close together to get an optimal view through the instrument. This does not affect the safety or<br>effectiveness of the device and we regard our device as equivalent to the predicate devices. |
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Image /page/9/Picture/1 description: The image shows a gray triangle with a white border. Inside the triangle is a white symbol that resembles a stylized letter "S" with a lightning bolt running through it. Below the symbol, the word "HEINE" is written in white, block letters. The logo appears to be a company or brand identifier.
Labeling on the products:
## HEINE OMEGA 500
Image /page/9/Picture/4 description: The image shows a head-mounted binocular indirect ophthalmoscope. The device is black and has a head strap that goes around the user's head. There are two eyepieces that the user looks through, and a light source that shines into the patient's eye. The ophthalmoscope is used to examine the retina and other structures of the eye.
total view from behind
Image /page/9/Picture/6 description: The image shows a close-up of a binocular indirect ophthalmoscope. The device is black and has two eyepieces with adjustable interpupillary distance. The manufacturer's name, "HEINE," and the country of origin, "GERMANY," are printed on the device. The serial number, "SN11200026728," is also visible.
operator's view
Image /page/9/Picture/8 description: The image shows a close-up of a piece of equipment, possibly a camera or some other type of device. The equipment is mostly gray and black in color. The device has a number of different parts, including a lens, a viewfinder, and a number of buttons and dials. The equipment appears to be in good condition and is well-maintained.
view from the left
Image /page/9/Picture/10 description: The image shows a close-up of a black, padded object. The object has a V-shaped design in the center, and it is surrounded by a black frame. The frame has several openings, and the object appears to be made of a soft material.
backside of the headband
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Image /page/10/Picture/1 description: The image shows a gray triangle with a white border. Inside the triangle is a white symbol that resembles a stylized letter "S" with a lightning bolt running through it. Below the symbol, the word "HEINE" is written in white, block letters. The logo appears to be for a company or organization, possibly in the medical or electrical field.
### Keeler Vantage Plus
Image /page/10/Picture/3 description: The image shows a close-up of a piece of equipment, possibly a measuring tool or a component of a larger machine. The device has a dark gray or black color and features a rectangular body with the word "VANTAGE" printed on it. The equipment also has a T-shaped base with two white buttons visible on the front.
All of the same of the latest of the states of the states of the states of the states of the states of the states of the states of the states of the states of the states of t
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total view
Image /page/10/Picture/5 description: The image shows a close-up of a head-mounted surgical headlight. The headlight is attached to a black headband. The light source is rectangular and has a lens on the left side. There is a knob on the side of the light source that is used to adjust the focus of the light.
operator's view
Image /page/10/Picture/7 description: The image shows a Keeler brand head-mounted binocular indirect ophthalmoscope. The ophthalmoscope is black and silver, and it is mounted on a white headband. The Keeler logo is visible on the headband. The ophthalmoscope is positioned on a white surface, and there are some blurry objects in the background.
view from the left
Image /page/10/Picture/9 description: The image shows a black electronic device with a curved shape and a strap. The device has a small, round component attached to the bottom. The strap is connected to the device on both sides, and it appears to be made of a flexible material.
backside of the headband
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Image /page/11/Picture/0 description: The image shows the word "HEINE" in a bold, sans-serif font. The letters are all capitalized and appear to be a dark gray or black color. The background is a light color, providing contrast to the text.
Image /page/11/Picture/1 description: The image shows the HEINE logo, which is a gray triangle with a white outline. Inside the triangle, there is a white caduceus symbol with the word "HEINE" written in white letters across the middle. The caduceus symbol is a medical symbol that features a staff with two snakes coiled around it.
## NEITZ IO-a LED
Image /page/11/Picture/3 description: The image shows a close-up of a medical device, possibly a head-mounted surgical lamp or similar instrument. The device is gray and has several adjustable components, including a central block with the word "HEINE" printed on it. The lower part of the device has the word "LED" on the left and the number "20-05" on the right.
Image /page/11/Picture/4 description: The image shows a close-up of a gray optical instrument. The instrument has two lenses on the front, with knobs on either side. There are also some numbers and markings on the top of the instrument. The instrument appears to be in good condition.
total view
operator's view
Image /page/11/Picture/7 description: The image shows a close-up of a piece of equipment. The equipment has a boxy shape with a few knobs and buttons on the side. There are also some wires connected to the equipment. The equipment is mounted on a stand, and there is a blurry object in the background.
view from the left
Image /page/11/Picture/9 description: The image shows a piece of equipment with a black control box on top of a black strap. The control box has a knob on top and a white button on the front. There are several wires connected to the control box, and the strap appears to be part of a head-mounted device.
backside of the headband
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Image /page/12/Picture/1 description: The image shows a logo with a triangle shape. Inside the triangle, there is a symbol of a snake winding around a staff, which is a common symbol associated with medicine and healthcare. Below the snake and staff symbol, the word "HEINE" is written in a stylized font. Below the word "HEINE" is another word that is difficult to read due to the image quality.
### Summary of Non-Clinical Performance Testing:
The HEINE OMEGA®500 indirect ophthalmoscope is tested according to the "Ophthalmoscope Guidance" in respect to optical radiation hazard with ophthalmoscopes (ISO 10943). Additionally testing in accordance with applicable requirements of ISO 15004-2 "Ophthalmic instruments - Fundamental requirements and test methods" has been performed.
### Conclusion:
HEINE Optotechnik believes that the HEINE OMEGA® 500 is substantially equivalent to the currently legally marketed devices. They do not introduce new indications for use, have the same technological characteristics and do not introduce new potential hazards or safety risks.
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#### DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/13/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes extending from its back, representing the department's mission to promote health and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle symbol. The logo is presented in black and white.
February 26, 2013
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Cont…
